StarFish Medical Blog: get the latest medical device innovation news

Apr 3

Arash Samimi in Business, Engineering, Industrial Design, Manufacturing, Product Development | No comments

Medical Device Design for the Developing World

“We need to think about medical device as a system that delivers an operational capability.”

I saw a picture of a dumping ground for medical devices in Malawi. This made me wonder – why are there so many nonfunctional and broken medical devices in low-income regions of the globe?

Apr 3

Lorenzo Gutierrez in Uncategorized | No comments

Microfluidics for molecular and serological diagnostic tests

More than a year into the pandemic, there have been over 120 million people infected by the COVID-19 virus globally and almost 3 million deaths. Over 400 million doses of COVID-19 vaccines have been administered¹.

Apr 3

Joris van der Heijden in Biotech, Product Development | No comments

Designing Point of Care Diagnostics

It is all about the sample

Point-Of-Care Testing (POCT) has seen a large uptake over the past year driven by the need for on-site testing due to the COVID-19 pandemic. We see that often companies focus their attention on one specific sample type and subsequent sample preparation (e.g. blood or nasopharyngeal samples) and build a platform and market around the constraints of that sample type.

Apr 3

Susan Bantroch in Biotech, Product Development | No comments

Simulated Fluids for POCT Development

An expensive pitfall when developing or optimizing a point-of-care device is to jump straight into using clinical samples to steer early design development. Developing or optimizing a point-of-care device is a multi-faceted process.

Apr 3

Nick Allan in Biotech, Product Development | No comments

TPP: The secret to efficient diagnostic device design

2020 highlighted the importance of rapid diagnostics. Many companies approached us in 2020 looking to develop a better COVID-19 diagnostic test. No matter what the technology, state of development or size of the company, we have found that the key differentiator between a successful medical device product and an unsuccessful one, was having a good, well-defined Target Product Profile (TPP) going into the development cycle.

Apr 3

Lynne Lowry in Business, Uncategorized | No comments

9 Questions for your medical device development partner search

You and your team have made the decision to outsource the development of your medical device. Now, how to pick the best development partner? Finding the right development partner can be a daunting task, even in the best of times.

Mar 4

Brian King in Engineering, Product Development | No comments

Medical device color management options

Why Colour-rendering Accuracy is Critical for Full-Colour Medical Device Color Management

“A picture is worth a thousand words.” That truism is no-less apt when it comes to medical devices, particularly when an accurate record or real-time presentation of tissue appearance is key to appropriate diagnosis and treatment.

Mar 3

Astero StarFish in Business, StarFish Culture | No comments

Employees Share 9 Surprises About Working in StarFish

Starting a new job can be risky. Interviews reflect everyone on their best behavior. What will it really be like a few months down the line? StarFish is full of company culture. While preparing our January issue on medtech careers and recruiting, our employees shared their biggest surprises about working at StarFish Medical.

Mar 2

Rade Gadzic in Eastern Region, Engineering, Product Development | No comments

Quickly verify environmental stress cracking (ESC)

The ability to quickly verify Environmental stress cracking (ESC) is important because it is one of the most common failure mechanisms in parts made of polymeric materials. Proper selection of polymers is crucial to the successful design, production and longevity of any product, but it is particularly vital to the purpose and usage of medical devices. In addition to standard mechanical and thermal properties, sensitivity to environmental stress cracking should be a major consideration, especially when dealing with polycarbonate.

Mar 2

Nigel Syrotuck in Business, Manufacturing, Product Development, Quality, Regulatory | 13 comments

RoHS 2 vs RoHS 3 impact on medical devices

Note: RoHS 3 is a colloquial term referring to Delegated Directive (EU) 2015/863, which is actually an amendment to RoHS 2 (Directive 2011/65/EU) rather than a standalone Directive. Though this terminology has become somewhat common (common enough to keep using the term here), it’s technically inaccurate. Originally published in April 2016, the article is updated on March 2, 2021 to include more details on the July 22, 2021 deadline.

RoHS 3 – The Trilogy is Complete

Are your medical devices RoHS compliant?

The Restriction of Hazardous Substances (RoHS) Directive has had a substantial and permanent effect on the materials that go into many of the electronic products we make.

Feb 4

Adam MacNeil in Engineering, Regulatory | No comments

Why it pays to dig deeper – IEC 60601

One of the key values at StarFish is that we “look deeper and solve the right problems.” This blog is about a situation where dig deeper – IEC 60601 saved me from potential problems later down the road.

Feb 4

Virginia Anastassova in Regulatory | No comments

How to benefit from FDA ASCA (Accreditation Scheme for Conformity Assessment) Pilot Program

FDA launched their pilot ASCA (Accreditation Scheme for Conformity Assessment) Program on September 25, 2020. The intent for the ASCA program is to utilize accredited third-party testing laboratories to assess premarket applicants’ declarations of conformity to consensus standards for safety, performance and biocompatibility. The final guidance outlining the accreditation scheme for the ASCA pilot program can be found here.

ABOUT US

BLOGARITHMIC THINKING

Medical Device Design for the Developing World

“We need to think about medical device as a system that delivers an operational capability.”

I saw a picture of a dumping ground for medical devices in Malawi. This made me wonder – why are there so many nonfunctional and broken medical devices in low-income regions of the globe?

Microfluidics for molecular and serological diagnostic tests

More than a year into the pandemic, there have been over 120 million people infected by the COVID-19 virus globally and almost 3 million deaths. Over 400 million doses of COVID-19 vaccines have been administered¹.

Designing Point of Care Diagnostics

It is all about the sample

Simulated Fluids for POCT Development

An expensive pitfall when developing or optimizing a point-of-care device is to jump straight into using clinical samples to steer early design development. Developing or optimizing a point-of-care device is a multi-faceted process.

TPP: The secret to efficient diagnostic device design

9 Questions for your medical device development partner search

You and your team have made the decision to outsource the development of your medical device. Now, how to pick the best development partner? Finding the right development partner can be a daunting task, even in the best of times.

Medical device color management options

“A picture is worth a thousand words.” That truism is no-less apt when it comes to medical devices, particularly when an accurate record or real-time presentation of tissue appearance is key to appropriate diagnosis and treatment.

Employees Share 9 Surprises About Working in StarFish

Quickly verify environmental stress cracking (ESC)

RoHS 2 vs RoHS 3 impact on medical devices

RoHS 3 – The Trilogy is Complete

Are your medical devices RoHS compliant?

The Restriction of Hazardous Substances (RoHS) Directive has had a substantial and permanent effect on the materials that go into many of the electronic products we make.

Why it pays to dig deeper – IEC 60601

One of the key values at StarFish is that we “look deeper and solve the right problems.” This blog is about a situation where dig deeper – IEC 60601 saved me from potential problems later down the road.

How to benefit from FDA ASCA (Accreditation Scheme for Conformity Assessment) Pilot Program

Categories

ABOUT US

BLOGARITHMIC THINKING

“We need to think about medical device as a system that delivers an operational capability.”

I saw a picture of a dumping ground for medical devices in Malawi. This made me wonder – why are there so many nonfunctional and broken medical devices in low-income regions of the globe?

More than a year into the pandemic, there have been over 120 million people infected by the COVID-19 virus globally and almost 3 million deaths. Over 400 million doses of COVID-19 vaccines have been administered1.

It is all about the sample

An expensive pitfall when developing or optimizing a point-of-care device is to jump straight into using clinical samples to steer early design development. Developing or optimizing a point-of-care device is a multi-faceted process.

You and your team have made the decision to outsource the development of your medical device. Now, how to pick the best development partner? Finding the right development partner can be a daunting task, even in the best of times.

“A picture is worth a thousand words.” That truism is no-less apt when it comes to medical devices, particularly when an accurate record or real-time presentation of tissue appearance is key to appropriate diagnosis and treatment.

RoHS 3 – The Trilogy is Complete

Are your medical devices RoHS compliant?

The Restriction of Hazardous Substances (RoHS) Directive has had a substantial and permanent effect on the materials that go into many of the electronic products we make.

One of the key values at StarFish is that we “look deeper and solve the right problems.” This blog is about a situation where dig deeper – IEC 60601 saved me from potential problems later down the road.

Categories

More than a year into the pandemic, there have been over 120 million people infected by the COVID-19 virus globally and almost 3 million deaths. Over 400 million doses of COVID-19 vaccines have been administered¹.